Research Compliance Analyst

Lincoln, Nebraska, Remote or Hybrid
Full or Part-Time
Position Summary – This position is responsible for conducting comprehensive research audits and monitoring of National Cancer Institute-sponsored clinical trials to ensure investigators and staff engaged in research activities are qualified, trained, and compliant with all aspects of federal, state and local policies and regulations governing clinical research. This position reviews internal regulatory documentation, informed consent forms, protocols, amendments, correspondence, deviation reports, drug storage and accountability, case report forms, study data, and adverse event reports. This position also determines overall protocol compliance which includes review of the consent process, eligibility criteria, and proper study agent administration. Medical records, laboratory data, and other source documentation are utilized to examine study data accuracy and completeness. This position prepares audit and monitoring reports based on findings, works with research management to create corrective and preventative action plans, and assists in the development of education and training with respect to the conduct of clinical trials. The Research Compliance Analyst is an integral member of the Human Research Protections Program. Under the direction of the Executive Director and in partnership with the Research Director, the Research Compliance Analyst promotes and facilitates a culture of compliance through audit activities designed to identify risk and support adherence to Federal, State, and Local Regulations and Guidelines. This includes but is not limited to providing educational programming and tools to facilitate compliant research, conducting quality assurance reviews of data to support reporting, and working with the research community to establish standards. The Research Compliance Analyst works closely with the Research Director to develop quality/compliance training programs and assists with the delivery of training programs. 
Education

Bachelor’s Degree in a related field  (Required)
Master’s Degree in a related field  (Preferred)

Experience

Three (3) or more years of clinical research experience  (Preferred)
Two (2) or more years of clinical trials auditing/monitoring experience  (Preferred)

Certifications

Industry-recognized certification (i.e., CCRC, CCRA, CCRP)  (Preferred)

Special Skills

Project management skills, including the ability to identify needs, develop action plans, and manage projects to completion. Ability to multitask and to work efficiently and independently  (Required)
Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care  (Required)

Bachelor’s Degree in a related field 
Project management skills, including the ability to identify needs, develop action plans, and manage projects to completion. Ability to multitask and to work efficiently and independently
Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care 
 

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